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α-fetoprotein test (Up-converting Phosphor Technology)
EUDAMEDClass C (EU MDR)
Ref HGUPT17Model Please see the IFU
Identity
- Trade Name
- α-fetoprotein test (Up-converting Phosphor Technology) EUDAMED
- Device Name
- α-fetoprotein test (Up-converting Phosphor Technology) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGUPT17 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700405644 EUDAMED
- Basic UDI-DI
- 697029753439LZ EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
α-fetoprotein test (Up-converting Phosphor Technology) by Beijing Hotgen Biotech Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697029753439LZ | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 17c1d631-1c1d-49c2-b1ad-ba3636e7a887 61 fields · synced Jun 19, 2026